In humans, we tested the hypothesis that a flat interface nerve electrode (FINE) placed around the femoral nerve trunk can selectively stimulate each muscle the nerve innervates. In a series of intraoperative trials during routine vascular surgeries, an eight-contact FINE was placed around the femoral nerve between the inguinal ligament and the first nerve branching point. The capability of the FINE to selectively recruit muscles innervated by the femoral nerve was assessed with electromyograms (EMGs) of the twitch responses to electrical stimulation. At least four of the six muscles innervated by the femoral nerve were independently and selectively recruited in all subjects. Of these, at least one muscle was a hip flexor and at least two were knee extensors. Results from the intraoperative experiments were used to estimate the potential for the electrode to restore knee extension and hip flexion through functional electrical stimulation. Normalized EMGs and biomechanical simulations were used to estimate joint moments and functional efficacy. Estimated knee extension moments exceed the threshold required for the sit-to-stand transition.

Abstract-Clinical interventions to restore standing or stepping by using nerve cuff stimulation require a detailed knowledge of femoral nerve neuroanatomy. We harvested eight femoral nerves with all distal branches and characterized the branching patterns and diameters. The fascicular representation of each distal nerve was identified and traced proximally to create fascicle maps of the compound femoral nerve in four cadaver specimens. Distal nerves were consistently represented as individual fascicles or distinct groups of fascicles in the compound femoral nerve. Branch-free length of the compound femoral nerve was 1.50 +/-0.47 cm (mean +/-standard deviation). Compound femoral nerve cross sections were noncircular with major and minor diameters of 10.50 +/-1.52 mm and 2.30 +/-0.63 mm, respectively. In vivo intraoperative measurements in six subjects were consistent with cadaver results. Selective stimulation of individual muscles innervated by the femoral nerve may therefore be possible with a single neural prosthesis able to selectively stimulate individual groups of fascicles.

Abstract-Implanted functional electrical stimulation (FES) systems for walking are experimentally available to individuals with incomplete spinal cord injury (SCI); however, data on short-term therapeutic and functional outcomes are limited. The goal of this study was to quantify therapeutic and functional effects of an implanted FES system for walking after incomplete cervical SCI. After robotic-assisted treadmill training and overground gait training maximized his voluntary function, an individual with incomplete SCI (American Spinal Injury Association grade C, cervical level 6-7) who could stand volitionally but not step was surgically implanted with an 8-channel receiver stimulator and intramuscular electrodes. Electrodes were implanted bilaterally, recruiting iliopsoas, vastus intermedius and lateralis, tensor fasciae latae, tibialis anterior, and peroneus longus muscles. Twelve weeks of training followed limited activity post-surgery. Customized stimulation patterns addressed gait deficits via an external control unit. The system was well-tolerated and reliable. After the 12-week training, maximal walking distance increased (from 14 m to 309 m), maximal walking speed was 10 times greater (from 0.02 m/s to 0.20 m/s), and physiological cost index was 5 times less (from 44.4 beats/m to 8.6 beats/m). Voluntary locomotor function was unchanged. The implanted FES system was welltolerated, reliable, and supplemented function, allowing the participant limited community ambulation. Physiological effort decreased and maximal walking distance increased dramatically over 12 weeks.

Evaluation of the Case Western Reserve University spiral nerve cuff electrode on the femoral nerve trunk was performed intraoperatively in four subjects undergoing femoral-popliteal bypass surgery. The threshold, nerve size and selective activation capabilities of the electrode were examined. The activation thresholds for the first muscle to be recruited were 6.3, 9, 10.6, and 37.4 nC with pulse amplitudes ranging from 0.3 to 1 mA. The femoral nerve was found to have an elliptical cross-section with a major axis average length of 9 mm (8-12 mm) and a minor axis length of 1.5 mm. In all four subjects selective activation of the sartorius was obtained. In two subjects, the rectus femoris could also be selectively activated and in one subject the vastus medialis was selectively activated. Each electrode had four independent contacts that were evaluated separately. Small air bubbles were formed in the space over some contacts, preventing stimulation. This occurred in one contact in each electrode, leaving three effective stimulation channels. This issue has been corrected for future studies.

Background Peripheral nerve stimulation with implanted nerve cuff electrodes can restore standing, stepping and other functions to individuals with spinal cord injury (SCI). We performed the first study to evaluate the clinical electrodiagnostic changes due to electrode implantation acutely, chronic presence on the nerve peri- and post-operatively, and long-term delivery of electrical stimulation. Methods A man with bilateral lower extremity paralysis secondary to cervical SCI sustained 5 years prior to enrollment received an implanted standing neuroprosthesis including composite flat interface nerve electrodes (C-FINEs) electrodes implanted around the proximal femoral nerves near the inguinal ligaments. Electromyography quantified neurophysiology preoperatively, intraoperatively, and through 1 year postoperatively. Stimulation charge thresholds, evoked knee extension moments, and weight distribution during standing quantified neuroprosthesis function over the same interval. Results Femoral compound motor unit action potentials increased 31% in amplitude and 34% in area while evoked knee extension moments increased significantly ( p < 0.01) by 79% over 1 year of rehabilitation with standing and quadriceps exercises. Charge thresholds were low and stable, averaging 19.7 nC ± 6.2 (SEM). Changes in saphenous nerve action potentials and needle electromyography suggested minor nerve irritation perioperatively. Conclusions This is the first human trial reporting acute and chronic neurophysiologic changes due to application of and stimulation through nerve cuff electrodes. Electrodiagnostics indicated preserved nerve health with strengthened responses following stimulated exercise. Temporary electrodiagnostic changes suggest minor nerve irritation only intra- and peri-operatively, not continuing chronically nor impacting function. These outcomes follow implantation of a neuroprosthesis enabling standing and demonstrate the ability to safely implant electrodes on the proximal femoral nerve close to the inguinal ligament. We demonstrate the electrodiagnostic findings that can be expected from implanting nerve cuff electrodes and their time-course for resolution, potentially applicable to prostheses modulating other peripheral nerves and functions. Trial registration ClinicalTrials.gov NCT01923662 , retrospectively registered August 15, 2013.